Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

Why Should You Attend:

Analytical methods play a critical role in development and manufacture of biologics. The methods should be suitable for intended use during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. It is also required that the methods must be maintained in a validated state with appropriate method performance during life cycle of the product.

In this presentation, an overview of the life cycle of an analytical method will be presented with emphasis on design of suitable method for intended purpose and maintaining sustainable compliance of the analytical methods during product life cycle.

Learning Objectives:

• To understand analytical method life cycle and regulatory expectations and requirements for the methods during product development
• To understand risks and inherent variability of analytical methods
• To learn in designing methods “suitable for intended purposes”
• How to continuously monitor method performance and achieve sustainable compliance of methods for regulatory requirements

Areas Covered in the Webinar:

• Analytical Method Life Cycle
• Role of Analytical Methods During Product Life Cycle
• Risks and Inherent Variability of Analytical Methods
• Design of Methods “Suitable for Intended Purposes”
• Continuous Monitoring of Method Performance
• Sustainable Compliance of Analytical Methods to Requirements

Who Will Benefit:

• Quality control
• Scientists and technicians involved in development and manufacturing operations of biological products
• R&D
• Regulatory Affairs

Instructor Profile:

Rajesh K. Gupta has a Ph.D. in microbiology and is the principal consultant at Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of biologics, working with both regulatory agencies and the industry. At FDA, CBER, he was a deputy director and the lab chief in the division of biological standards and quality control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods.

His previous experience includes his tenure at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH) in USA, and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.

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